[A comparative study of the efficacy and safety Zhibitai and atorvastatin].

ABSTRACT

OBJECTIVE: To compare the lipid lowing effect and the clinical safety between intensive therapy with Chinese medicine Zhibitai and atorvastatin in patients with moderate and high risk of atherosclerosis. METHODS: All the patients were randomly divided in to a Zhibitai group (n = 85) receiving 480 mg of Zhibitai orally twice a day or an atorvastatin group (n = 84) receiving 10 mg atorvastatin orally once daily. Blood lipoproteins, myocardial enzymes, liver and renal function were measured before treatment and at the fourth and eighth week after therapy, while high sensitive c reactive protein (hs-CRP), P-selectin, matrix-metall proteinase-9 (MMP-9) and soluble intercellular adhering molecule-1 (SICAM-1) were detected before treatment and eighth week after therapy in all patients. RESULTS: TC and LDL-C were significantly decreased while HDL-C was increased in both groups after 4 and 8 weeks treatment (P < 0.05). TG was decreased in Zhibitai group after 4 and 8 weeks of treatment, but it was decreased in atorvastatin group only after 8 weeks of treatment. Inflammatory factors such as hs-CRP, P-selectin, MMP-9, SICAM-1 were decreased significantly (all P < 0.01), but there was no significant difference between the two groups. There were no difference in liver and kidney function, myocardial enzymes and incidence of muscle-ache and digestive system side reaction. CONCLUSIONS: Besides the lipoprotein disorder, inflammatory factors in patients with moderate and high risk of atherosclerosis could be regulated with intensive therapy of Zhibitai. Most importantly, it is safe to use Zhibitai clinically.